6 of 6 Remote/Hybrid CAPA Jobs in London

experience in Complaints Management for Medical Device Strong understanding of FDA, EU MDR/IVDR requirements and Reporting Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485and 14971, FDA21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both ...

building and managing high-performing Quality teams. Expert command of the core Quality toolkit: QMS, ISO 13485, design controls, ISO 14971 risk management, CAPA, validation, and supplier quality. Experience hosting and leading audits, including annual certification audits. Preferred audit certifications (ASQ CQE/CQA/CMQ-OE, RAC, Lead Auditor ...

MHRA Software and AI as a Medical Device programme, MDCG guidance, FDA guidance, IMDRF) and assess impact on products and the QMS. Support CAPA and internal audit follow-ups where regulatory root causes are identified. What We’re Looking For 3 to 6 years' Regulatory Affairs experience in Medical Devices ...

activities in line with ISO 14971 , including hazard analysis, risk evaluation and mitigation strategies. Supporting post‐market surveillance, vigilance and complaints investigations , ensuring robust CAPA and documentation. Working as part of, or leading, cross‐functional project teams , managing quality deliverables, tracking actions and supporting timely decision‐making. Qualifications … environments. A well‐developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering . Experience with supplier quality, audits, CAPA and document control . Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders. We know the skill-gap and ...

supports remediation efforts to project audit observations Promote GCP compliance by authoring records (e.g., project audit reports) Perform process improvement activities and incident/CAPA investigations Provide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and … 3+ years in a Clinical QA role in Life Sciences Experience with Quality Management Systems (e.g., documentation and record management, computer system validation, investigations, CAPA programs) Working knowledge of Quality Principles as manifest in ISO 9001 or QSRs, GCP regulations and guidelines Proven technical writing skills Comfortable in a fast ...

both technical support teams and clinical teams. Participates in audit and regulatory inspection preparation activities and assist in the development and delivery of CAPA to time and quality, when applicable. Participates in inspection/audit preparation activities and assist in the development and execution of CAPA plans, when applicable. Continuously ...